Kornimate/medical-research-clean huggingface dataset:
long-term follow-up in patients with prostate cancer after surgery

Conditions: Cancer Survivor; Prostate Carcinoma

Summary: this clinical trial studies how well a long-term follow-up works in patients with prostate cancer after surgery. long-term follow-up data may serve as a resource to help ask clinical questions, describe health-related quality of life and long-term complications related, and facilitate future studies focusing on interventions to improve health status and health-related quality of life in prostate cancer survivors.

primary objectives: i. to provide comprehensive long-term follow-up care to prostate cancer survivors at the city of hope who underwent definitive surgical therapy. ii. to use the information obtained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to serve as a resource that will help answer clinical questions, generate and test hypotheses, describe the incidence of long-term complications, and facilitate future studies focusing on interventions for long-term complications of prostate cancer and its therapy. iii. to use the information gained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to describe health-related quality of life (hrql) concerns and to serve as a resource to facilitate future studies focusing on interventions to improve health status and hrql in prostate cancer survivors. outline: patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.

Eligibility criteria:
inclusion criteria: * diagnosis of prostate cancer * treated with a definitive surgical procedure at city of hope * at least one year post surgical treatment for prostate cancer * no history of recurrent, progressive, or metastatic disease * currently stable disease or no evidence of disease * no prior treatment of prostate cancer with radiation or chemotherapy * no history of other urologic cancer (e.g., bladder cancer, renal cell carcinoma) in addition to prostate cancer * note: patients who develop recurrence while participating in the prostate cancer survivorship clinic will be referred back to their urologist and may resume participation in the survivorship clinic when deemed appropriate by their treating physician exclusion criteria: * current treatment with testosterone replacement or androgen deprivation therapy * treatment for another noncutaneous cancer within the past 2 years
a study to describe the effect of impaired hepatic function of the pharmacokinetics of palbociclib

Conditions: Healthy, Hepatic Insufficiency

Summary: this is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.

this is a 4-cohort single period study. the four cohorts will consist of healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function. each cohort will receive the same treatment consisting of a single oral 75mg dose of palbociclib administered with food. serial pk samples will be drawn up to 120 hours post dose for the cohort consisting of healthy volunteers, and will continue until up to 192 hours post-dose for the cohorts of hepatic impairment subjects.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18 to 40 kg/m2; and a total body weight \>50 kg (110 lbs) * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study * subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures exclusion criteria: * any condition possibly affecting drug absorption (eg, gastrectomy) * a positive urine drug screen * pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for 90 days after the last dose of investigational product * history of sensitivity to heparin or heparin-induced thrombocytopenia * blood donation of approximately 1 pint (500 ml) or more within 56 days prior to dosing * unwilling or unable to comply with the lifestyle guidelines described in this protocol * use of tobacco or nicotine products in excess of 5 cigarettes per day (or equivalent) * history of sensitivity to palbociclib

Keywords: palbociclib, pd-0332991, hepatic impairment
pharmacokinetics and pharmacodynamics, efficacy and safety of omalizumab in japanese children (6 - 15 years)

Conditions: Allergic Asthma

Summary: the primary purpose of this study is to examine whether the geometric mean of serum free ige level at 24 weeks of the treatment period in japanese pediatric patients (6 to 15 years of age) reaches under 25 ng/ml (target level). the investigators will also assess how well pk/pd data of japanese children fit the global pk-pd modeling built from those of caucasian adults and children, and assess efficacy and safety data in japanese pediatric patients which will fulfill the japanese health authority requirement for approval. data obtained from the study is intended to be used to support the registration of pediatric indication of omalizumab in japan.


Eligibility criteria:
inclusion criteria: * body weight and serum total ige level within the dosing table range; body weight of 20 to 150 kg and serum total ige levels of 30 to 1300 iu/ml * receiving asthma long-term control medications of high dose ics (\>200 µg/day fp or equivalent) and two or more controller medications out of ltra, theophylline, sodium cromoglycate, laba, or ocss 12 weeks prior to the run-in period. these medications should be kept stable for 4 weeks prior to the run-in period and during the run-in period (except for management of asthma attacks/exacerbations) * having 2 or more asthma exacerbations requiring treatment with a doubling of the maintenance ics dose for at least 3 days and/or systemic (oral or iv) corticosteroids in the past; one of these exacerbations must have occurred in the previous 12 months, which is documented in the medical record * demonstrating inadequately controlled asthma symptoms during the last 14 day run-in period based on the patient diary which meet any of the following: asthma symptoms every day; night-time symptoms in ≥2 out of the last 14 days (missing data to be treated as a day with no symptoms); limitation of daily activities in ≥2 out of the last 14 days (missing data to be treated as a day with no limitations) exclusion criteria: * with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s) * with positive skin reaction to the study drug at the run-in period * with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study drug or drug related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin) * with platelet level ≤ 100,000/µl (100 x 109/l) at the run-in period * who are taking intra-muscular depo-steroids within 4 weeks of the run-in period * who are taking systemic (oral or iv) corticosteroids for reasons other than asthma within 4 weeks of the run-in period (patients with chronic ocss use for asthma are allowed) other protocol-defined inclusion/exclusion criteria may apply

Keywords: omalizumab allergic asthma pediatric patients
safety and immunogenicity of vi-dt typhoid conjugate vaccine (bio farma) in adults and children (phase i)

Conditions: Safety Issues

Summary: this study is to assess the safety of vi-dt vaccine in adults and children.

to describe the safety of this vaccine following first and second dose immunization. to assess preliminary information of immunogenicity following vi-dt vaccine immunization.

Eligibility criteria:
inclusion criteria: 1. healthy 2. subjects/parents have been informed properly regarding the study and signed the informed consent form 3. subject/parents will commit to comply with the instructions of the investigator and the schedule of the trial exclusion criteria: 1. subject concomitantly enrolled or scheduled to be enrolled in another trial 2. evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°c ) 3. known history of allergy to any component of the vaccines 4. history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection 5. subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks). 6. any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives 7. pregnancy \& lactation (adults) 8. individuals who have previously received any vaccines against typhoid fever. 9. subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose. 10. individuals who have a previously ascertained typhoid fever. 11. history of alcohol or substance abuse. 12. subject planning to move from the study area before the end of study period.
zoledronic acid for osteoporotic fracture prevention (zest ii)

Conditions: Osteoporotic Fractures; Osteoporosis, Postmenopausal

Summary: the goal of this study is to perform the first fracture reduction clinical trial with a potent antiresorptive agent (intravenous zoledronic acid) in the most vulnerable long-term care population.

although close to 85% of frail women in long-term care (ltc) facilities have osteoporosis and the risk of osteoporotic fractures is nearly 10 times that of community dwelling elderly, few are treated and studies are scarce. it is postulated that in frail, ltc women an annual infusion of zoledronic acid, an antiresorptive therapy for osteoporosis, will: 1. be effective demonstrated by fracture reduction; 2. be safe. to address these hypotheses, up to 1000 female ltc residents age 65 and older will be screened in order to enroll 310 eligible for randomization in a 3 year, randomized, double-blind, calcium and vitamin d controlled trial with the antiresorptive agent zoledronic acid. use of an intravenous, once yearly agent avoids concerns of oral bisphosphonate side effects, poor absorption and burden on staff. participants will reside in the long-term care settings associated with the division of geriatric medicine, university of pittsburgh and will include women with multiple comorbid conditions, functional and cognitive impairment, and limited mobility.

Eligibility criteria:
inclusion criteria: * women age ≥65 years including those using assistive devices to maximize generalizability if they: 1. reside in long-term care (ltc); 2. have: * osteoporosis by axial bone density (spine, hip or forearm bone mineral density (bmd) t-score ≤ -2.5 sd); or * a previous adult fragility fracture of the spine or hip; or, * would be treated based on frax national osteoporosis foundation (nof) treatment thresholds of a 10 year risk of ≥ 20% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck bmd. exclusion criteria: * men because osteoporosis is less common in men and our initial zest 1 study only included women. * institutionalized women with subacute illnesses surviving or discharged in \< 3 years. * women currently on bisphosphonate, denosumab, or teriparatide therapy or who have been on a bisphosphonate for greater than 1 year during the previous 2 years because bisphosphonates are long acting. * patients with a calculated creatinine clearance \< 35 ml/min or who have a contraindication for bisphosphonates (allergy, hypocalcemia).

Keywords: bone loss frail geriatric women nursing home patients long-term care patients osteoporosis osteoporotic fractures
biochemical approach to measuring surgical trauma

Conditions: Total Knee Replacement

Summary: this study will examine the magnitude and time course of changes in circulating (serum and plasma) biomarker concentrations associated with musculoskeletal injury created by total knee replacement surgery. the sensitivity to injury will be characterized by the changes in mean serum concentration before and after surgery. specificity for the injured state will be evaluated comparing the baseline to peak change (injury response) with the pre-surgery to follow-up baseline fluctuation (i.e. measurement noise).


Eligibility criteria:
inclusion criteria * age 18 to 75 * no musculoskeletal injury requiring medical attention in the past 3 months other than entirely related to worsening symptoms of the operative knee or spinal level. * no musculoskeletal injury producing pain in the previous 2 weeks. * no inflammatory disease other than osteoarthritis) * no exercise with weights in the 2 weeks before surgery.

Keywords: knee replacement arthroplasty
high-intensity interval training and fat mass losses

Conditions: Overweight and Obesity; Men

Summary: the aims of this study was to compare two isoenergetic hiit (high-intensity interval training) programs (cycling vs. running) on body composition, substrate oxidation at rest and during a moderate exercise, muscle functionality, glycaemic control, lipid profile, inflammation, maximal aerobic capacity (vo2max) and gut microbiota composition in men with overweight or obesity. the investigators hypothesized that both programs could decrease total, abdominal and visceral fat mass but due to differences in muscle solicitation, metabolism adaptation and blood flow, and that running could favors greater fat mass losses.

the first aim of this study was to compare two isoenergetic hiit programs (cycling vs. running) on body composition in men with overweight or obesity. 20 men with overweight or obesity should completed hiit program three times a week during twelve weeks. i) high intensity interval training - bike (hiie bike) 10 cycles of speeding up for 45 s at 80-thphr followed by pedaling slowly (40% thphr) for 1m30s (37min30s) ii) high intensity interval training - run (hiie run) 9 cycles of speeding up for 45 s at 80-thphr followed by pedaling slowly (40% thphr) for 1m30s (35min15s) body composition will be measured before and after hiit program by dual-energy x-ray absorptiometry (dxa).

Eligibility criteria:
inclusion criteria: * men (18 to 65 years old) * with overweight or obesity (bmi \> 25 kg/m2 and ≤ 40 kg/m2) exclusion criteria: * medical contraindications to intense physical activity, * painful joints, * taking ß-blocker

Keywords: cycling running high-intensity interval training fat mass visceral tissue health
characterization of gut microbiota composition and activity after a daily supplementation of 4.5 g/day of chitinglucan fibre during 3 weeks in at-cardiometabolic risk volunteers

Conditions: Cardiometabolic Risk; Abdominal Obesity

Summary: the aim of this study is to demonstrate the beneficial effects on gut microbiota composition and activity of the diary intake of insoluble fiber (extract from aspergillus niger) for three weeks. the first studies about the fiber have shown a favorable gut microbiota modulation and an improvement of metabolic parameters like ldl cholesterol. in addition to fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases, polyunsaturated fatty acid, short chain fatty acid (scfa) after a rich-fiber breakfast (= 15 grams) and a nutritional challenge test at lunch. the gastrointestinal tolerance of fiber intake and the intestinal transit modification will be also followed during all the study.


Eligibility criteria:
inclusion criteria: * healthy * non-smokers * body mass index between 25 and 35 kg/m2 * waist circumference \ 94 cm for men * fiber intake \<25g/day exclusion criteria: * medical history of digestive surgery or disease * current or recent (\<12 weeks) intake of antibiotics or gastro-intestinal medicinal product * current probiotics, prebiotics, fiber complement, and/or any products modulation gut transit * feeding particular diet such as vegetarian diet or hyperprotein diet * current weight loss diet * pregnant or lactating woman or woman who did not use effective contraception * drinking more than 3 glasses of alcohol per day (\>30g/day)

Keywords: chitin-glucan gut microbiota fecal short chain fatty acid (scfa) cardiometabolic risk nutritional challenge test biomarkers
umbrella study for single patient treatments in oncology

Conditions: Advanced Cancer; Rare Diseases

Summary: the purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments.

the unique umbrella protocol is an overarching framework to study precision medicine in patients with precise molecular data, who have exhausted all established treatment options and who are not eligible for any of the ongoing trials. there is no additional visit or procedure required to participate in this study. participants who have received/who may receive the following treatments may join the study and will be assigned to a study cohort (group): * group 1 - health canada approved/marketed drug(s) used on or off-label as standard of care (soc) * group 2 - drugs accessed from special access program (sap) * group 3 - non-marketed investigational agents under the unique framework, data from participants will be evaluated. the following data will be collected: * demographic data (for example: sex, race, month and year of birth) * medical history * cancer characteristics including biomarkers * treatment history * response to treatment

Eligibility criteria:
inclusion criteria \& exclusion criteria: patient's existing genomic information from tumor molecular profiling will be discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and medical oncology departments to decide n of 1 treatment for the patient. the discussion will surround the best next therapeutic option in the patient's cancer subtype with or without clear standard of care guidelines. therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.
sample collection study in patients with suspected melanoma utilizing dermtech's non-invasive adhesive patch biopsy kits

Conditions: Melanoma (Skin); Pigmented Skin; Nevus

Summary: a multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. all suspicious lesions should meet at least one of the "abcde" criteria.

a multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. all suspicious lesions should meet at least one of the "abcde" (asymmetry, border, color, diameter, evolving) criteria. patients will be consented for the study and screened against the inclusion and exclusion criteria. once the patient is determined to be acceptable for the study they will be assigned a unique patient number and tissue collection will begin. tissue from the lesion will be collected using dermtech's non-invasive adhesive patch kit according to the instructions for use followed by surgical biopsy. digital dermoscopy of the lesion is preferred but not required.

Eligibility criteria:
inclusion criteria: 1. males and females at least 21 years of age 2. have a pigmented lesion suspicious for melanoma the pigmented lesion meets at least one of the "abcde" criteria 3. the pigmented lesion mst be at least 3mm and not more than 16mm in diameter 4. patient is willing to follow the start of care to test and treat the pigmented lesion as determined by the treating physician 5. willing to have dermtech adhesive patch biopsies performed 6. must be able to complete study procedures as required by the protocol 7. willing to provide informed consent to participate in this trial exclusion criteria: 1. require a surgical biopsy or excision of the lesion of interest prior to the dermtech non-invasive patch biopsy(ies) 2. has an ulcerated or bleeding lesion that could confound the biopsy results 3. has a suspicious lesion(s) in an area that was previously surgically biopsied 4. has a lesion that is classified as "clinically" evident melanoma appropriate for excision 5. the lesion to be sampled is on the mucosal surface, palmoplantar surface or other area where adhesive patch biopsies cannot be performed 6. has a known sensitivity to adhesive patches 7. any significant medical condition that would indicate an unreasonable risk to the patient or potential interference with the study 8. lesion is in a location were sufficient removal of non-vellus hair cannot be achieved (e.g., scalp) 9. suspected non-melanoma skin cancer 10. patients with contraindication(s) to surgical biopsy -

Keywords: pigmented lesion assay (pla) dermtech
effect of vilanterol on methacholine challenge results

Conditions: Asthma

Summary: the study will assess the degree of bronchoprotection provided by the ultra long-acting beta2 agonist vilanterol against methacholine-induced bronchoconstriction.

this will be a double-blind, three-way crossover study comparing combination vilanterol+fluticasone with fluticasone monotherapy and a placebo (vilanterol is not available as a monotherapy). the order in which the treatments are given will be randomized and each treatment will be separated by a minimum one-week washout. fifteen asthmatic participants will be recruited from the local community. methacholine challenge testing (mct) with the two-minute tidal breathing protocol will be used to quantify the bronchoprotective effects (if any) of each treatment against methacholine-induced bronchoconstriction. each participant will undergo a total of nine methacholine challenges. after a baseline methacholine challenge, the randomized treatment (identity unknown to investigator or participant) will be administered through an ellipta® (multi-dose dry powder inhaler). thirty minutes following treatment administration, a second methacholine challenge will be performed. at 24 hours post-treatment, each participant must re-visit the lab for one methacholine challenge. the same process will be followed for each treatment.

Eligibility criteria:
inclusion criteria: * men and women aged 18 or older * stable mild-to-moderate asthma * baseline methacholine pc20 less than or equal to 8mg/ml * fev1 greater than or equal to 65% of predicted exclusion criteria: * use of long-acting anticholinergic or long-acting beta2 agonist within 30 days of study * pregnant or nursing * diabetes * hypokalemia * cardiovascular, prostate, kidney, or urinary retention problems * lactose-intolerant * allergy-induced asthma symptoms or upper respiratory tract infection within four weeks of study * current smokers * past smokers with smoking history \>10 pack years

Keywords: methacholine airway hyperresponsiveness
genotype, clinical features and imaging of neuroradiological abnormalities in cadasil

Conditions: CADASIL; CADASIL (Diagnosis)

Summary: the project aims to retrospectively and prospectively analyze a population of cadasil patients in order to study the natural history of the disease by correlating the symptom spectrum with genetic risk and specific neuroradiological and biological markers - stratifying patients according to their disease risk, this could contribute to the discovery of personalized therapeutic targets.


Eligibility criteria:
inclusion criteria: * patients of either sex older than 18 years of age; * finding of a pathogenic mutation on genetic analysis of notch3; * in the absence of unambiguous mutation, presence of characteristic deposits (gom) within small vessels at skin biopsy exclusion criteria: * do not meet the diagnostic criteria of cadasil; * are unable to give consent for the study due to aphasic or cognitive impairment or because they are deceased at the time of enrollment and their next of kin refuse to give consent for study participation.

Keywords: cadasil notch3